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Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the

Michael J Peluso1, Lynda Dee2,3,4,5, Shirley Shao1

  • 1Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|August 26, 2020
PubMed

Insights

Resuming human immunodeficiency virus (HIV) cure research during the SARS-CoV-2 pandemic requires careful risk mitigation. This viewpoint outlines strategies for safely reopening HIV cure trials, focusing on study design, consent, and implementation.

Area of Science:

  • Virology
  • Clinical Trials
  • Public Health

Background:

  • The COVID-19 pandemic presents challenges to resuming clinical research.
  • HIV cure trials involve complex protocols, including analytic treatment interruption.
  • Ethical and safe resumption of research requires careful planning.

Purpose of the Study:

  • To discuss an approach for reopening an HIV cure clinical trial during the SARS-CoV-2 pandemic.
  • To highlight key considerations for safe and ethical research resumption.
  • To provide recommendations for other HIV cure research groups.

Main Methods:

  • This viewpoint discusses a specific approach to reopening an HIV cure trial.
  • Focus on risk assessment and mitigation strategies.
  • Emphasis on participant safety, informed consent, and education.

Main Results:

  • The abstract does not contain specific results but outlines a framework for safe research resumption.
  • Key considerations for study design, informed consent, and implementation are discussed.
  • Recommendations are provided for navigating research during a pandemic.

Conclusions:

  • Safely resuming HIV cure research during the SARS-CoV-2 pandemic is feasible with meticulous planning.
  • Participant safety and ethical conduct are paramount.
  • The discussed approach can inform other research groups aiming to restart HIV cure studies.
Keywords:
COVID-19HIV cure–related trialsSARS-CoV-2analytical treatment interruptionsrisk mitigation

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